Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot s 161020, 161021, 161024, 161025, 161027, 161028, 161031, 161101, 161104, 101107, 101108, 161109, 161109, 161110, 161111, 161114, 161121, 161122, 161122, 161123, 161124, 161125, 161128, 161129, 161130, 161206, 161207, 161208, 161209, 161212, 161219, 161220, 161221, 161222, 1612223, 161226, 161227, 161228, 170109, 170112, 170113, 170116, 170117, 170120, 170123, 170124, 170125, 170126, 170127, 170130, 170131, 170201
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Terumo Medical Corp
- Reason for Recall:
- An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Product Codes/Lot Numbers:
Lot s 161020, 161021, 161024, 161025, 161027, 161028, 161031, 161101, 161104, 101107, 101108, 161109, 161109, 161110, 161111, 161114, 161121, 161122, 161122, 161123, 161124, 161125, 161128, 161129, 161130, 161206, 161207, 161208, 161209, 161212, 161219, 161220, 161221, 161222, 1612223, 161226, 161227, 161228, 170109, 170112, 170113, 170116, 170117, 170120, 170123, 170124, 170125, 170126, 170127, 170130, 170131, 170201
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0226-2018
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